Spinal construct

ABSTRACT

A spinal construct comprises a fastener including a head. A member includes an inner surface defining a cavity configured for disposal of the head and a groove configured for disposal of a band that is engageable with the head to connect the fastener and the member. The member includes a transverse rod. A coupling member is engageable with the inner surface. Implants, systems, instruments and methods are disclosed.

TECHNICAL HELD

The present disclosure generally relates to medical devices for thetreatment of spinal disorders, and more particularly to a surgicalimplant system including a bone fastener and a related method.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, discectomy, microdiscectomy,corpectomy, decompression, lam inectomy, laminotomy, foraminotomy,facetectomy and implantable prosthetics. As part of these surgicaltreatments, spinal constructs such as vertebral rods are often used toprovide stability to a treated region. Rods redirect stresses away froma damaged or defective region while healing takes place to restoreproper alignment and generally support the vertebral members. Duringsurgical treatment, one or more rods and bone fasteners can be deliveredto a surgical site. The rods may be attached via the fasteners to theexterior of two or more vertebral members. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a spinal construct is provided. The spinal constructcomprises a fastener including a head. A member includes an innersurface defining a cavity configured for disposal of the head and agroove configured for disposal of a band that is engageable with thehead to connect the fastener and the member. The member further includesa transverse rod. A coupling member is engageable with the innersurface. In some embodiments, implants, systems, instruments and methodsare disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a cross section view of components of the system shown in FIG.1;

FIG. 3 is a cross section view of the components shown in FIG.

FIG. 4 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 5 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 6 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 7 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 8 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 9 is a cross section view of the components shown in FIG. 8;

FIG. 10 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure; and

FIGS. 11, 12, 13 are cross section views of components of one embodimentof a surgical system illustrating assembly.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system including a bone fastener. In one embodiment, aspinal implant system includes a spinal construct having a spinal rodand a screw receiver. In some embodiments, the spinal construct includesa reduced dorsal profile with vertebrae.

In some embodiments, the spinal implant system comprises a longitudinalelement, such as, for example, a rod including a screw receiver member.In some embodiments, the screw receiver member is configured tofacilitate engagement with a head of a bone screw. In some embodiments,the spinal implant system comprises a screw receiver including aretaining member, a compression member and/or a housing. In someembodiments, the housing may be monolithically formed with the rod. Insome embodiments, the housing is welded and/or connected by fasteningelements with the rod. In some embodiments, the housing is configured tofacilitate connection with the bone screw head. In some embodiments, therod is connected with the screw by various screw connection mechanisms,such as, for example, a collet and/or taper lock. In some embodiments,the rod includes one or a plurality of screw receivers.

In some embodiments, the spinal implant system includes a rod configuredfor attachment to a spherical head of a bone screw and connectable withone or a plurality of tulip head bone screws and/or pedicle screws. Insome embodiments, the spinal implant system includes a screw receiverattached with a single bone screw without a tulip head and including arod connected with one or a plurality of tulip head bone screws and/orpedicle screws. In some embodiments, the spinal implant system includesa screw receiver attached with one or a plurality of bone screws withouta tulip head. In some embodiments, the spinal implant system includes ascrew receiver including a rod connected with a first bone screw withouta tulip head at a first end and a second bone screw without a tulip headat a second end such that the rod attaches the bone screws. In someembodiments, the spinal implant system provides a low profile spinalconstruct that connects one or more bone screws without a tulip headwith one or a plurality of separate tulip head bone screws and/orpedicle screws.

In some embodiments, the spinal implant system is employed with a methodsuch that the spinal construct includes one or a plurality of tulip headbone screws and/or pedicle screws fastened along one or more vertebrallevels and a screw receiver connected with a bone screw without a tuliphead fastened to a single vertebral level. In some embodiments, thespinal construct includes a rod having one or a plurality screwreceivers configured for connection with one or a plurality of bonescrews. In some embodiments, the spinal construct can be utilized as asuperior connection to reduce a profile adjacent to a non-fused facetjoint.

In some embodiments, the spinal construct includes a locking member, Insome embodiments, the spinal construct includes a compression member. Insome embodiments, the spinal construct includes a retaining memberexpansion chamber. In some embodiments, the spinal construct includes aretaining member, In some embodiments, the spinal construct includes abone screw. In some embodiments, the spinal construct includes a screwreceiver.

In some embodiments, the spinal implant system is employed with a methodof assembly such that the locking member is preassembled with the rod, aretaining member and a compression member. In some embodiments, thelocking member is connected with the compression member such that themembers translate along an axis of the locking member as the lockingmember is actuated and/or rotated. In some embodiments, the rod ismonolithically formed with the screw receiver. In some embodiments, therod is welded and/or integrally assembled with the screw receiver.

In some embodiments, the spinal construct includes a screw receiverhaving a rod extending therefrom such that the rod is extends in anoffset orientation to accommodate anatomy and/or implants disposed atother spine levels. In some embodiments, the rod extends in an offsetdorsal orientation and/or an offset coronal orientation.

In some embodiments, the spinal implant system comprises a modular screwsystem. In some embodiments, the spinal implant system comprises basecomponent that is pre-assembled with a bone screw. In some embodiments,the spinal implant system comprises screw assemblies and screw receiverassemblies that may be joined together during manufacturing orintra-operatively, such as, for example, during a surgical procedure inan operating room.

In some embodiments, a bone screw assembly includes a head having a baseand a screw shaft. In some embodiments, a screw receiver includes acrown, a body and a snap ring. In some embodiments, a snap ring isengaged in a retaining groove in the body and provisionally engaged tothe crown. In some embodiments, a snap ring is engaged to a part, suchas, for example, a sleeve that maintains the snap ring centered. In someembodiments, the present system is employed with a method of assemblysuch that during assembly the base drives and/or translates the crown orsleeve upwards to force the snap ring to expand and disengage the crown.In some embodiments, the method includes the step of engaging the headwith the screw receiver such that the snap ring engages a retaininggroove in the screw receiver and creates a permanent assembly of a bonefastener.

In some embodiments, the present system is employed with a method ofassembly including the step of initially engaging a screw receiver witha head of a bone screw. In some embodiments, the method includes thestep of expanding a snap ring such that the snap ring is expanded by thehead forcing a crown upwards in the screw receiver. In some embodiments,this configuration allows the crown to disengage from the snap ring. Insome embodiments, the method includes the step of collapsing the snapring such that as the head travels into the screw receiver, the snapring collapses in a retaining groove and the bone fastener ispermanently assembled,

In some embodiments, the spinal implant system comprises a spinalconstruct that can be assembled on a surgical table or in-situ. In someembodiments, the spinal construct is assembled with a force of less than50 Newtons (N). In some embodiments, the spinal construct is selectivelycoupled with a non-instrumented assembly. In some embodiments, thenon-instrumented assembly comprises manually engaging a head of a bonescrew with a screw receiver. In some embodiments, the non-instrumentedassembly comprises manually engaging the head in a pop-on engagementwith the screw receiver. In some embodiments, a force required tomanually engage the head with the screw receiver in a non-instrumentedassembly is in a range of 2 to 50 N. In some embodiments, a forcerequired to manually engage the head with the screw receiver in anon-instrumented assembly is in a range of 5 to 10 N. In someembodiments, a head of a bone screw is manually engaged with a screwreceiver in a non-instrumented assembly, as described herein, such thatremoval of the screw receiver from the head requires a force and/or apull-out strength of at least 5000 N. In some embodiments, thisconfiguration provides manually engageable components of a bone fastenerthat are assembled without instrumentation, and subsequent to assembly,the assembled components have a selected pull-out strength and/or can bepulled apart, removed and/or separated with a minimum required force.

In some embodiments, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the present disclosure may be employed with other ostealand bone related applications, including those associated withdiagnostics and therapeutics. In some embodiments, the disclosed spinalimplant system may be alternatively employed in a surgical treatmentwith a patient in a prone or supine position, and/or employ varioussurgical approaches to the spine, including anterior, posterior,posterior mid-line, lateral, postero-lateral, and/or antero-lateralapproaches, and in other body regions. The present disclosure may alsobe alternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thespinal implant system of the present disclosure may also be used onanimals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical systemincluding a spinal construct, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are also disclosed. Referenceis made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-3, there are illustrated components of a surgical system,such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites, For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,superelastic metallic alloys (e.g., Nitinol, super elasto-plasticmetals, such as GUM METAL®), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyimide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 includes a spinal construct 12. Spinal implantsystem 10 is employed, for example, with an open or mini-open, minimalaccess and/or minimally invasive including percutaneous surgicaltechnique and includes one or more spinal constructs 12 for treatment ata surgical site within a body of a patient, for example, a section of aspine to treat various spine pathologies, such as those describedherein. In some embodiments, the components of spinal implant system 10are configured to deliver and introduce components of a spinal construct12 that includes implants, such as, for example, one or more receivers,spinal rods, bodies, sleeves, connectors, plates and/or fasteners.Spinal construct 12 forms one or more components of a surgical treatmentimplanted with tissue for positioning and alignment to stabilize atreated section of vertebrae. Spinal construct 12 provides a low orreduced profile construct disposed along vertebrae, for example,adjacent a non-fused facet joint, as described.

Spinal construct 12 includes a fastener, such as, for example, a bonescrew 100 connectable with a member, such as, for example, a receiver14. Screw receiver 14 includes a wall 16. Wall 16 includes an innersurface 18 that defines a cavity 20. Cavity 20 is configured fordisposal of a head 102 of bone screw 100, as described herein. Wall 16extends along an axis X1, as shown in FIG. 2, In some embodiments, wall16 may extend in alternate configurations relative to axis X1, such as,for example, arcuate, offset, staggered and/or angled portions. Cavity20 is substantially circular. In some embodiments, all or only a portionof cavity 20 may have alternate cross section configurations, such as,for example, closed, V-shaped, W-shaped, oval, U-shaped, oblong,polygonal, irregular, uniform, non-uniform, offset, staggered, and/ortapered. In some embodiments, spinal construct 12 may include one or aplurality of receivers 14.

Surface 18 defines a groove 22 configured for disposal of a band, suchas, for example, a circumferential ring 24. Ring 24 includes acircumference that extends between ends defining an opening, such as,for example, a gap 26, which facilitates expansion and contraction.Groove 22 includes a portion, such as for, example, a circumferentialchannel 30 having a diameter d1 and a portion, such as for, example, acircumferential channel 32 having a diameter d2, as shown in FIG. 2. Insome embodiments, diameter d2 is greater than diameter d1.

Channel 32 is disposed adjacent and proximal to channel 30. Channel 32is separate from channel 30 by a protrusion, such as, for example, a lip34. In some embodiments, bone screw 100 is manually engageable withreceiver 14 and/or bone screw 100 is coupled with receiver 14 in anon-instrumented assembly such that ring 24 translates from and intochannels 30, 32, and over lip 34, as described herein. Ring 24 isexpandable and resilient between a contracted and/or capture orientationand an expanded orientation, as described herein. In some embodiments,ring 24 facilitates manual engagement of receiver 14 and bone screw 100such that receiver 14 is attached with bone screw 100 in anon-instrumented assembly, as described herein.

In some embodiments, wall 16 defines a slot 40 configured for disposalof a part, such as, for example, a crown 42, as described herein. Slot40 is defined by a surface 44 of wall 16. In some embodiments, all oronly a portion of surface 44 may have alternate surface configurationsto enhance engagement with crown 42, such as, for example, rough,arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured.

Crown 42 includes a wall 46 having an end surface 48 and an end surface50, as shown in FIG. 3. Surface 48 is configured for engagement with acoupling member, as described herein. Surface 50 defines a curvedportion of crown 42 engageable with bone screw 100, as described herein.In some embodiments, all or only a portion of surface 50 may havealternate cross section configurations, such as, for example, oval,oblong, polygonal, irregular, uniform, non-uniform, offset, staggered,and/or tapered.

Receiver 14 includes an inner surface 60. A portion of surface 60includes a thread form 62. Thread form 62 is configured for engagementwith a coupling member, such as, for example, a setscrew 64 to fixposition and/or orientation of bone screw 100 within cavity 20 relativeto one or more components of spinal construct 12 and/or tissue. In someembodiments, surface 60 may be disposed with the coupling member inalternate fixation configurations, such as, for example, friction fit,pressure fit, locking protrusion/recess, locking keyway and/or adhesive.In some embodiments, all or only a portion of surface 60 may havealternate surface configurations to enhance engagement with setscrew 64such as, for example, rough, arcuate, undulating, mesh, porous,semi-porous, dimpled and/or textured.

Setscrew 64 is actuated for translation along axis X1 to fix or releasebone screw 100 and receiver 14. Setscrew 64 is configured for engagementwith crown 42 and/or head 102 to facilitate fixation of bone screw 100with receiver 14. Setscrew 64 is disposable between a non-lockingorientation such that bone screw 100 is moveable relative to receiver 14and a locked orientation such that setscrew 64 fixes bone screw 100 withreceiver 14 relative to one or more components of spinal construct 12and/or tissue.

In some embodiments, setscrew 64 is pre-assembled with receiver 14, forexample, setscrew 64 can be connected with receiver in-situ or on a backtable of an operating room during a surgical procedure, or at amanufacturing facility. In some embodiments, setscrew 64 is integrallyconnected with receiver 14. In some embodiments, setscrew 64 isconnected with crown 42 such that actuation of setscrew 64simultaneously axially translates setscrew 64 and crown 42 relative toreceiver 14 to fix position and/or orientation of bone screw 100 withincavity 20 relative to one or more components of spinal construct 12and/or tissue.

Receiver 14 includes an outer surface 70. A spinal rod 72 extends fromsurface 70 along an axis L1. Rod 72 extends transverse to axis X1. Insome embodiments, rod 72 may extend in alternate orientations relativeto axis X1 such as, for example, arcuate, tapered, perpendicular,parallel and/or other angular orientations such as acute or obtuse,co-axial and/or may be offset or staggered. Rod 72 extends between anend 74 and an end 76. In some embodiments, rod 72 may have various crosssection configurations, such as, for example, circular, oval, oblong,polygonal, irregular, uniform, non-uniform, variable, offset and/ortapered. Rod 72 includes a surface 78 configured for connection with areceiver of one or a plurality of bone fasteners, as described herein.

In some embodiments, rod 72 is monolithically formed with receiver 14.In some embodiments, rod 72 is integrally connected with receiver 14 bywelding. In some embodiments, rod 72 is integrally connected withreceiver 14 by fastening elements and/or instruments to facilitateconnection. In one embodiment, as shown in FIG. 4, rod 72 extends alongaxis L1 and includes an extension 80 that extends along an axis L2.Extension 80 is dorsally offset such that axis L2 is offset relative toaxis L1. Extension 80 is connected to rod 72 via an angled transition toorient rod 72 dorsally and provide clearance for an existing spinalimplant and/or anatomy. In one embodiment, as shown in FIG. 5, rod 72extends along axis L1 and includes an extension 82 that extends along anaxis L2. Extension 82 is coronally offset such that axis L2 is offsetrelative to axis L1. Extension 82 is connected to rod 72 via an angledtransition to orient rod 72 coronally and provide clearance for anexisting spinal implant and/or anatomy. In some embodiments, rod 72 canbe offset in various axial, planar and/or other orientations, such as,for example, a transverse plane, a coronal plane, a sagittal plane,perpendicular and parallel.

Bone screw 100 includes head 102 and a shaft 104, Head 102 includes aspherical configuration. In some embodiments, head 102 includes asurface 106 that defines a plurality of ridges 108 to improve purchaseof head 108 with crown 42. Head 102 includes a tool engaging portion 110configured to engage a surgical tool or instrument, as described herein.In some embodiments, portion 110 includes a hexagonal cross-section tofacilitate engagement with a surgical tool or instrument, as describedherein. In some embodiments, portion 110 may have alternativecross-sections, such as, for example, rectangular, polygonal, hexalobe,oval, or irregular.

Shaft 104 is configured to penetrate tissue, such as, for example. bone.In some embodiments, shaft 104 includes an outer surface having anexternal thread form. In some embodiments, the external thread form mayinclude a single thread turn or a plurality of discrete threads.

In some embodiments, receiver 14 is manually engageable with head 102 ina non-instrumented assembly such that ring 24 translates from disposalwith channel 30 and into channel 32, as described herein. In someembodiments, manual engagement and/or non-instrumented assembly ofreceiver 14 and head 102 includes coupling without use of separateand/or independent instrumentation engaged with the components to effectassembly. In some embodiments, manual engagement and/or non-instrumentedassembly includes a practitioner, surgeon and/or medical staff graspingreceiver 14 and bone screw 100 and forcibly assembling the components.In some embodiments, manual engagement and/or non-instrumented assemblyincludes a practitioner, surgeon and/or medical staff grasping receiver14 and bone screw 100 and forcibly snap fitting the components together,as described herein. In some embodiments, manual engagement and/ornon-instrumented assembly includes a practitioner, surgeon and/ormedical staff grasping receiver 14 and bone screw 100 and forcibly popfitting the components together and/or pop fitting receiver 14 onto bonescrew 100, as described herein. In some embodiments, a force in a rangeof 2-50 N is required to manually engage receiver 14 and bone screw 100and forcibly assemble the components. For example, a force in a range of2-50 N is required to snap fit and/or pop fit assemble receiver 14 andbone screw 100. In some embodiments, a force in a range of 5-10 N isrequired to manually engage receiver 14 and bone screw 100 and forciblyassemble the components. For example, a force in a range of 5-10 N isrequired to snap fit and/or pop fit assemble receiver 14 and bone screw100.

In some embodiments, spinal construct 12 includes one or a plurality ofbone fasteners 150. Bone fastener 150 comprises a head 152 and anelongated shaft 154 configured for penetrating tissue. Head 152 includesa receiving portion configured for disposal of rod 72. In someembodiments, head 152 includes tulip heads and/or bone fastener 150comprises a pedicle screw. In some embodiments, head 152 is manuallyengageable with shaft 154 in a non-instrumented assembly, as describedherein.

In some embodiments, one or more of bone fasteners 150 and/or bonescrews 100 may be engaged with tissue in various orientations, such as,for example, series, parallel, offset, staggered and/or alternatevertebral levels. In some embodiments, one or more fasteners 150 and/orbone screws 100 may comprise multi-axial screws, sagittal angulationscrews, pedicle screws, mono-axial screws, uniplanar screws, facetscrews, fixed screws, tissue penetrating screws, conventional screws,expanding screws, wedges, anchors, buttons, clips, snaps, frictionfittings, compressive fittings, expanding rivets, staples, nails,adhesives, posts, fixation plates and/or posts.

In assembly, operation and use, as shown in FIGS. 6 and 7, spinalimplant system 10, similar to the systems and methods described herein,includes spinal construct 12 and is employed with a surgical procedurefor treating disorders of the spine, such as those described herein. Insome embodiments, one or all of the components of spinal implant system10 can be delivered as a pre-assembled device or can be assembled insitu.

The surgical treatment including spinal construct 12 can be used forcorrection and alignment in stabilization of a treated section ofvertebrae V. In an exemplary use, a medical practitioner obtains accessto a surgical site including vertebrae V via a posterior surgicalapproach. In some embodiments, the surgical site may be accessed in anyappropriate manner, such as through incision and retraction of tissues.In some embodiments, spinal implant system 10 can be used in anyexisting surgical method or technique including open surgery, mini-opensurgery, minimally invasive surgery and percutaneous surgicalimplantation, whereby vertebrae V is accessed through a mini-incision,or sleeve that provides a protected passageway to the area.

Spinal construct 12 is disposed with vertebrae V in connection with thesurgical procedure. In some embodiments, one or more spinal constructs12 are disposed in a linear orientation along vertebrae V. In someembodiments, one or more spinal constructs 12 are disposed withvertebrae V in alternate orientations relative to each other, such as,for example, parallel, perpendicular, adjacent, co-axial, arcuate,offset, staggered, transverse, angular and/or relativeposterior/anterior orientations and/or at alternate vertebral levels.

Pilot holes are made in vertebrae V in a selected orientation. Bonefasteners 150 and bone screw 100, as described herein, are aligned withthe pilot holes and fastened with the tissue of vertebrae V. In someembodiments, bone fasteners 150 are disposed in a selected orientation,as described herein, with one or more vertebral levels of vertebrae V.In some embodiments, bone screw 100 is disposed in a selectedorientation with a single vertebral level of vertebrae V.

The components of spinal construct 12 are assembled, which includesdisposing crown 42 with slot 40, ring 24 with channel 30 and aligninghead 102 with receiver 14, as descried herein. Bone screw 100 isconnected with receiver 14, as shown in FIG. 7, and rod 72 extends fromreceiver 14 in a selected orientation, as described herein, relative tobone fasteners 150 and/or vertebrae V.

Head 102 translates through and relative to ring 24, over lip 34 intochannel 32, into an expanded orientation, as described herein. Head 102engages crown 42 and ring 24 is resiliently biased to the captureorientation such that receiver 14 is attached with bone screw 100, asdescribed herein. Disengagement of bone screw 100 from receiver 14 isresisted and/or prevented.

Rod 72 is oriented and/or manipulated such that surface 78 is disposedwith heads 152 of bone fasteners 150 along one or more vertebral levelsof vertebrae V. Setscrew 64 is disposed in a non-locking orientation andactuated for translation along axis Xl. Setscrew 64 engages crown42/head 102, and is disposed in a locked orientation to fix the selectedposition and orientation of bone screw 100 and receiver 14 withvertebrae V. In some embodiments, setscrews (not shown) are fastenedwith heads 152 and surface 78 to fix the selected position andorientation of rod 72 with bone fasteners 150.

In some embodiments, spinal implant system 10 includes an agent, whichmay be disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the fixation elementswith vertebrae. In some embodiments, the agent may be HA coating. Insome embodiments, the agent may include one or a plurality oftherapeutic agents and/or pharmacological agents for release, includingsustained release, to treat, for example, pain, inflammation anddegeneration.

In some embodiments, the use of microsurgical and image guidedtechnologies may be employed to access, view and repair spinaldeterioration or damage, with the aid of spinal implant system 10. Thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.

In one embodiment, as shown in FIGS. 8-13, spinal implant system 10,similar to the systems and methods described herein, includes a spinalconstruct 212, similar to spinal construct 12 described herein. Spinalconstruct 212 includes a receiver 214, similar to receiver 14 describedherein. Receiver 214 includes a wall 216 having a surface 218 thatdefines a cavity 220. Wall 216 extends along an axis X2, as shown inFIG. 9. Cavity 220 is configured for disposal of a head 302 of a bonescrew 300, as described herein.

Surface 218 defines a groove 222 configured for disposal of acircumferential ring 224, similar to ring 24 described herein. Ring 224includes a circumference that extends between ends defining a gap, whichfacilitates expansion and contraction thereof. Groove 222 includes acircumferential channel 230 that accommodates expansion of ring 224. Insome embodiments, upon disposal of ring 224 with groove 222, the surfaceof groove 222 resists and/or prevents axial translation of ring 224relative to axis X2.

Ring 224 is expandable and resilient between a contracted and/or captureorientation, and an expanded orientation, similar to that describedherein. Ring 224 facilitates manual engagement of receiver 214 and bonescrew 300 such that a receiver 214 is attached with bone screw 300 in anon-instrumented assembly, as described herein. In some embodiments,ring 224 is expandable and resilient between a contracted and/or captureorientation and an expanded orientation for assembly of receiver 214with bone screw 300, as shown and described for example with regard toFIGS. 11-13.

Surface 218 defines a slot 240 configured for disposal of a part, suchas, for example, a crown 242 and a sleeve 244. Crown 242 is configuredfor disposal within cavity 220. Crown 242 includes a wall 246 having anend surface 248 and an end surface 250. Surface 248 is configured forengagement with a setscrew (not shown), similar to setscrew 64 describedherein. Surface 250 defines a curved portion of crown 242 configured forengagement with head 302 of bone screw 300, as described herein.

Surface 248 defines a flange 252 configured for mating engagement with aportion of surface 218. In some embodiments, flange 252 engages aportion of surface 218 in a keyed connection. In some embodiments,engagement of flange 252 and surface 218 prevents rotation and/or axialtranslation of crown 242 relative to surface 218 of receiver 214.

Sleeve 244 includes a surface 254 that defines a cavity, such as, forexample, a groove 256. In some embodiments, groove 256 extends about allor a portion of surface 254. Groove 256 includes a surface 258 and asurface 260. Surface 258 is disposed at an angle relative to axis X2 todefine a ramp. Surface 260 is disposed at an angle relative to axis X2to define a ramp. The ramps of surfaces 258, 260 are oriented in spacedapart relation. An intermediate surface 262 is disposed between theramps, Surface 262 is substantially even and circumferentially disposedabout sleeve 244. In some embodiments, the ramps of surfaces 258, 260are selectively inclined to resist and/or prevent displacement of ring224 from channel 230 to provisionally fix sleeve 244 with receiver 214.In some embodiments, the inclination of the ramps of surfaces 258, 260facilitate disengagement of ring 224 from groove 256 upon axialtranslation of sleeve 244, as described herein. In some embodiments,surfaces 258, 260 are oriented substantially perpendicular to axis X2.In some embodiments, groove 256 does not include inclined surfaces, asdescribed above, and alternatively includes a protrusion or a lipconfigured to engage ring 224.

Sleeve 244 is configured for translation within slot 240 along surface218. Sleeve 244 translates relative to crown 242 and receiver 214 withinslot 240. Translation of sleeve 244 within slot 240 moves sleeve 244between a configuration, as shown in FIG. 11, such that ring 224 isdisposed within channel 230 and groove 256 to provisionally fix sleeve244 relative to receiver 214 and a configuration, as shown in FIG, 13,such that ring 224 remains disposed within channel 230 and a base 320,attached with bone screw 300, to fix bone screw 300 with receiver 214,as described herein.

Bone screw 300 includes a head 302 and a shaft 304. Head 302 includes aspherical configuration. In some embodiments, head 302 includes asurface 306 that defines a plurality of ridges 308 to improve purchaseof head 308 with crown 242. Head 302 includes a tool engaging portion310 configured to engage a surgical tool or instrument, as describedherein. In some embodiments, portion 310 includes a hexagonalcross-section to facilitate engagement with a surgical tool orinstrument, as described herein. In some embodiments, portion 310 mayhave alternative cross-sections, such as, for example, rectangular,polygonal, hexalobe, oval, or irregular.

Shaft 304 is configured to penetrate tissue, such as, for example, bone.In some embodiments, shaft 304 includes an outer surface having anexternal thread form. In some embodiments, the external thread form mayinclude a single thread turn or a plurality of discrete threads.

Bone screw 300 includes base 320, which has a wall 322. Wall 322includes a surface 324. Surface 324 defines a cavity 326 configured fordisposal of head 302. Surface 324 facilitates engagement of head 302with base 320 via a pressure and/or force fit connection.

In some embodiments, surface 324 includes mating elements, such as, forexample, index elements 328. In some embodiments, index elements 328include a protrusion 330 configured to limit rotation about a singleaxis disposed in a plane relative to receiver 214. In some embodiments,rotation of shaft 304 in a second plane is resisted and/or prevented dueto the interface of head 302 and index elements 328. In someembodiments, receiver 214 is connected to a selected crown 242 tocomprise a multi-axial receiver. In some embodiments, receiver 214 isconnected to a selected crown 242 to comprise a uni-axial receiver. Insome embodiments, receiver 214 is connected to a selected crown 242 tocomprise a fixed axis receiver to resist and/or prevent movement ofshaft 304 relative to receiver 214. In some embodiments, receiver 214comprises one or more fixed axis receivers, multi-axial receivers anduni-axial receivers. In some embodiments, spinal implant system 10comprises a spinal implant kit, which includes alternate crowns, such asthose described herein. In some embodiments, spinal implant system 10comprises a spinal implant kit, which includes alternate receivers,screws and crowns.

In some embodiments, base 320 may be disposed with head 302 in alternatefixation configurations, such as, for example, friction fit, pressurefit, locking protrusion/recess, locking keyway and/or adhesive. Base 320is configured for rotation relative to head 302. In some embodiments,base 320 is configured for rotation in range of 360 degrees relative tohead 302 to facilitate positioning of shaft 304 with tissue. In someembodiments, base 320 is configured for selective rotation in range of360 degrees relative to and about head 302 such that shaft 304 isselectively aligned for rotation in a plane relative to receiver 214,and rotation in a second plane is resisted and/or prevented.

Wall 322 includes a surface 340. Surface 340 defines a groove 342.Groove 342 includes a surface 344 and a surface 346. Surfaces 344, 346are oriented substantially perpendicular to axis X2. In someembodiments, surfaces 344, 346 may be disposed in various orientationsand/or inclinations, such as, for example, transverse and/or at angularorientations, such as acute or obtuse relative to axis X2. Surface 344is oriented in spaced apart relation relative to surface 346, Anintermediate surface 348 is disposed between surfaces 344, 346. Surface348 is substantially even and circumferentially disposed about groove342. In some embodiments, surfaces 344, 346, 348 may be disposed aboutall or only a portion of groove 342. Groove 342 is configured fordisposal of ring 224 to prevent displacement of ring 224 from channel230 and to permanently fix receiver 214 with bone screw 300, as shown inFIG. 13. Base 320 is configured for axial translation relative to head302 within slot 240, as described herein.

For example, base 320 is assembled with head 302 and a surface 350engages sleeve 244 to release sleeve 244 from ring 224, as shown in FIG.11. As base 320 engages sleeve 244 and translates, in a direction shownby arrow B in FIG. 11, the ramp of surface 260 engages ring 224 andsurface 260 slides over ring 224 to release sleeve 244 from ring 224,Ring 224 expands into channel 230, as shown in FIG. 12. With ring 224expanded into channel 230, base 320 and head 302 axially translaterelative to receiver 214 within slot 240 to align groove 342 withchannel 230. Expansion of ring 224 via engagement with surface 260facilitates axial translation of bone screw 300 into slot 240. Alignmentof groove 342 with channel 230 allows ring 224 to resiliently contractto the capture orientation, as shown in FIG. 13, for disposal of ring224 within groove 342 and channel 230. Ring 224 is fixed within channel230 and groove 342, Surfaces 344, 346 resist and/or preventdisengagement of ring 224 from channel 230 and groove 342 to permanentlyassemble bone screw 300 with receiver 214.

Receiver 214 includes an inner surface 270. A portion of surface 270includes a thread form 272. Thread form 272 is configured for engagementwith the setscrew, described herein. The setscrew is actuated fortranslation along axis X2 to fix or release bone screw 300 and receiver214, similar to that described herein. The setscrew is configured forengagement with crown 242 and/or head 302 to facilitate fixation of bonescrew 300 with receiver 214. The setscrew is disposable between anon-locking orientation such that bone screw 300 is moveable relative toreceiver 214 and a locked orientation such that the setscrew fixes bonescrew 300 with receiver 214 relative to one or more components of spinalconstruct 212 and/or tissue, similar to that described herein.

Receiver 214 includes an outer surface 280. A rod 282, similar to rod 72described herein, extends from surface 280 along an axis L3. In someembodiments, rod 282 extends transverse to axis X2. In some embodiments,rod 282 is connectable with one or a plurality of fasteners, similar torod 72 described herein.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-20. (canceled)
 21. A spinal construct comprising: a fastenercomprising a base, a head and a shaft connected to the head, the headbeing disposed in the base such that the base extends about the head,the base defining a first groove configured for disposal of a band; amember including a body having opposite inner and outer surfaces, theinner surface defining a cavity having the base disposed therein, themember including a rod having a first end directly engaging the outersurface and an opposite second end, the body defining a second grooveextending into the inner surface; a crown disposed in the cavity; and apart disposed in the cavity and comprising a third groove, wherein thebase is configured to move relative to the member to move the spinalconstruct from a first orientation in which the band is disposed in thesecond and third grooves to a second orientation in which the band isdisposed in the first and second grooves to connect the member with thefastener.
 22. The spinal construct recited in claim 21, furthercomprising the band.
 23. The spinal construct recited in claim 21,wherein the first groove extends into an outer surface of the base. 24.The spinal construct recited in claim 23, wherein an opposite innersurface of the base defines an aperture, the head being disposed in theaperture.
 25. The spinal construct recited in claim 21, wherein thefirst end of the rod is permanently fixed with the outer surface. 26.The spinal construct recited in claim 21, wherein the crown is spacedapart from the rod.
 27. The spinal construct recited in claim 21,wherein the part includes opposite inner and outer surfaces, the thirdgroove extending into the outer surface of the part.
 28. The spinalconstruct recited in claim 27, wherein the inner surface of the partdirectly engages an outer surface of the crown.
 29. The spinal constructrecited in claim 21, wherein the base is monolithic and extends 360degrees about the head.
 30. The spinal construct recited in claim 21,wherein the inner surface further defines a threaded bore configured forengagement with a threaded setscrew, the threaded bore being coaxialwith the cavity.
 31. The spinal construct recited in claim 30, whereinthe cavity has a maximum diameter less than a maximum diameter of thethreaded bore.
 32. The spinal construct recited in claim 21, wherein thecrown is stationary relative to the member as the spinal construct movesfrom the first orientation to the second orientation.
 33. The spinalconstruct recited in claim 21, wherein the head is engaged with the basevia a force fit connection.
 34. The spinal construct recited in claim21, wherein the base includes a flange extending outwardly from an outersurface of the base, the body including opposite proximal and distalsurfaces.
 35. The spinal construct recited in claim 34, wherein thedistal surface of the body is spaced apart from a proximal surface ofthe flange when the spinal construct is in the first orientation. 36.The spinal construct recited in claim 34, wherein the distal surface ofthe body directly engages a proximal surface of the flange when thespinal construct is in the second orientation.
 37. The spinal constructrecited in claim 34, wherein the distal surface of the body is spacedapart from a proximal surface of the flange when the spinal construct isin the first orientation, the distal surface of the body directlyengaging the proximal surface of the flange when the spinal construct isin the second orientation.
 38. The spinal construct recited in claim 21,wherein a proximal surface of the base directly engages a distal surfaceof the part as the spinal construct moves from the first orientation tothe second orientation.
 39. A spinal construct comprising: a band; afastener comprising a monolithic base, a head and a shaft connected tothe head, the head being disposed in the base such that the base extendsabout the head, the base defining a first groove; a member including abody having opposite inner and outer surfaces, the inner surfacedefining a cavity having the base disposed therein, the member includinga rod having a first end directly engaging the outer surface and anopposite second end, the rod being monolithically formed with the body,the body defining a second groove; a crown disposed in the cavity; and apart disposed in the cavity and comprising a third groove, wherein thebase is configured to move relative to the member to move the spinalconstruct from a first orientation in which the band is disposed in thesecond and third grooves to a second orientation in which the band isdisposed in the first and second grooves to connect the member with thefastener.
 40. A spinal construct comprising: a band; a fastenercomprising a monolithic base, a head and a shaft connected to the head,the head being disposed in the base such that the base extends about thehead, the base defining a first groove; a member including a body havingopposite inner and outer surfaces, the inner surface defining a cavityhaving the base disposed therein, the member including a rod having afirst end directly engaging the outer surface and an opposite secondend, the rod being monolithically formed with the body, the bodydefining a second groove; a crown disposed in the cavity; and a partdisposed in the cavity and comprising a third groove, wherein the baseis configured to move relative to the member to move the spinalconstruct from a first orientation in which the band is disposed in thesecond and third grooves to a second orientation in which the band isdisposed in the first and second grooves to connect the member with thefastener, the crown being stationary relative to the member as thespinal construct moves from the first orientation to the secondorientation.